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RECRUITING
NCT06188676
PHASE3

Multicenter Study of Safety and Efficacy Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed PMBL

Sponsor: National Research Center for Hematology, Russia

View on ClinicalTrials.gov

Summary

This compares the effects of nivolumab at a fixed dose of 40 mg with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.

Official title: Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2022-04-01

Completion Date

2029-04-01

Last Updated

2024-01-03

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

Ciclofosfamida

DRUG

Doxorubicin Hydrochloride

Adriamycin

DRUG

Etoposide Phosphate

Etopophos

DRUG

Prednisolone

Prednisolonum

DRUG

Rituximab

Chimeric Anti-CD20 Antibody

DRUG

Vincristine Sulfate

Oncovin

DRUG

Filgrastim

G-CSF

DRUG

Pegfilgrastim

PEG-filgrastim

DRUG

Nivolumab 40 mg in 4 ml Injection

Opdivo

Locations (1)

National Research Center for Hematology

Moscow, Russia